Mirion Captus 4000e Thyroid Uptake System Recall: Tension Bolt Failure Risk
Mirion recalls Captus 4000e Thyroid Uptake Systems (models 5430-30151, 5430-30152, 5430-30154) due to potential tension bolt failure causing spring arm to drop 25 inches. Affected units shipped April 2019–Feb 2024 with serial numbers 940548–941398.
Use caution until it’s fixed
Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5 cm) from the ground.
What happened, in plain English
Mirion recalls three specific models of thyroid uptake systems because a tension bolt could fail, causing the spring arm to drop 25 inches to the ground. This poses a risk of injury if the device falls on someone nearby. Read more at govinfonow.com/recall/1134712-mirion-captus-4000e-thyroid-uptake-system-recall-tension-bolt-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/1134712-mirion-captus-4000e-thyroid-uptake-system-recall-tension-bolt-failure · Updated October 4, 2026 · FDA enforcement record: FDA #Z-3193-2026
Cite this page
“Mirion Captus 4000e Thyroid Uptake System Recall: Tension Bolt Failure Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/1134712-mirion-captus-4000e-thyroid-uptake-system-recall-tension-bolt-failure. Based on FDA recall #Z-3193-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3193-2026%22&limit=1).
Why it’s dangerous
The tension bolt in the device could fail, causing the spring arm to drop unexpectedly to about 25 inches (63.5 cm) from the ground. This height means the arm could strike someone nearby during medical procedures.
Who’s affected
Healthcare professionals using the Captus 4000e Thyroid Uptake System for nuclear medicine tests are most at risk. Patients and staff near the device during use could be injured if the spring arm falls.
How to tell if you have this one
Check for model numbers 5430-30151, 5430-30152, or 5430-30154 on the device. Devices shipped between April 2019 and February 2024 with serial numbers 940548 through 941398 that have not been replaced with the redesigned arm are affected.
- Brand
Mirion- Category
Medical device
What to do — step by step
Check Device Model
Identify the model number on the device to confirm if it matches 5430-30151, 5430-30152, or 5430-30154.
Verify Serial Number
Check the serial number on the device to see if it falls between 940548 and 941398.
Contact Manufacturer
Reach out to Mirion Technologies (Capintec), Inc. for guidance on whether the device needs replacement with the redesigned arm.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of ALGERIA, AUSTRIA, BANGLADESH, BRASIL, Brazil, CANADA, CHILE, Costa Rica, Ecuador, France, Hanoi Vietnam, Hong Kong, INDIA, ISRAEL, ITALY, Malaysia, Philippines, POLAND, Saudi…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using this device immediately?
No, but you should check if your device is affected and contact Mirion if needed. The recall requires verification before taking action.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3193-2026 (July 20, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3193-2026 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.